This is a summary of the European public assessment report (EPAR) for Gardasil. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Gardasil.
Therapeutic Indication
Gardasil is a vaccine for use from the age of 9 years for the prevention of: * premalignant genital lesions (cervical, vulvar and vaginal), premalignant anal lesions, cervical cancers and anal cancers causally related to certain oncogenic Human Papillomavirus (HPV) types; * genital warts (condyloma acuminata) causally related to specific HPV types. See sections 4\.4 and 5\.1 for important information on the data that support this indication. The use of Gardasil should be in accordance with official recommendations.
Therapeutic Area (MeSH)
ATC Code
J07BM01
ATC Item
N/A
Pharmacotherapeutic Group
Vaccines
Active Substance (Summary)
INN / Common Names
EMA Name
Gardasil
Medicine Name
Gardasil
Aliases
N/ANo risk management plan link.
